Desyncra For Tinnitus Therapy System TI10.04EU_01

GUDID EDYGTI1004EU01

Desyncra Operating GmbH

Tinnitus masking application software

• Primary Device ID: EDYGTI1004EU01
• NIH Device Record Key: af04ca69-6f2d-408c-a765-5931769e7eba
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Desyncra For Tinnitus Therapy System
• Version Model Number: Size XL
• Catalog Number: TI10.04EU_01
• Company DUNS: 313625455
• Company Name: Desyncra Operating GmbH
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	EDYGTI1004EU01 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151558

FDA Product Code

• KLW: Masker, Tinnitus

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-07-06
• Device Publish Date: 2018-03-02

On-Brand Devices [Desyncra For Tinnitus Therapy System]

• EDYGTI1004EU01: Size XL
• EDYGTI1003EU01: Size L
• EDYGTI1002EU01: Size M
• EDYGTI1001EU01: Size S